Pradaxa, an anti-coagulant drug marketed by Boehringer Ingelheim Pharmaceuticals, enjoyed an unusually smooth (and quick) ride towards FDA approval. Rather than spending months pouring over clinical studies and safety data, FDA employees instead approved Pradaxa based primarily on a single study and did so in just six months. Below are […]
Category: Defective Drugs
There have been some significant developments in the bisphosphonate litigation over the past few months. Now that the two-year anniversary of the FDA’s safety alert over atypical femur fractures has passed, we anticipate that nearly 70 to 80% of the bisphosphonate cases in the country have now been filed. The […]
The Institute of Medicine (IOM) is taking the U.S. Food and Drug Administration (FDA) to task. In a new report, the IOM says the FDA should conduct more regular reviews of drugs to better catch and track safety issues. In order to better inform patients and the doctors who treat […]
The Top Ten of anything usually designates the ‘best’ but not in this case. An online report from Adverse Events Inc., an independent company that analyzes the FDA’s database of Adverse Event Reporting System (AERS), has just issued its Top Ten list of Dangerous Drugs for the second quarter Q2 […]
I was thrilled to hear that some of our elected members of Congress are finally working on proactive legislation that might benefit all of us. This is especially encouraging after watching with much discouragement the high level of discord and dysfunction that has become commonplace in the Capitol. Recently, some […]
The U.S. Food and Drug Administration (FDA) wants to remind the public what a good job it’s been doing in monitoring drugs both before and after they are marketed. In a report issued over the weekend, April 21, “Advances in FDA’s Safety Program for Marketed Drugs,” the agency pats itself […]
The Judicial Panel on Multi-District Litigation issued an order on April 17, 2012, establishing MDL No. 2342 styled In Re: Zoloft (setraline hydrochloride) Products Liability Litigation. This order will establish coordinated multi-district proceedings in the federal court in the Eastern District of Pennsylvania for lawsuits that have been filed on […]
Bloomberg is reporting today that Bayer has now settled approximately 500 of the more than 10,000 lawsuits pending against the German drug manufacturer. The reports indicate that the cases were confidentially settled for the sum of $110 million, or slightly more than an average of $200,000 per case. Settlement negotiations […]
The “antipsychotic” class of drugs is distributed liberally in nursing homes. Antipsychotics including Risperdal, Seroquel, Zyprexa, and Abilify, are frequently given to the elderly who are suffering from dementia so they are easier to control. It’s a handy tool in a nursing home that is understaffed and needs to find […]
A newly published study finds that first-time users of a class of drugs to treat osteoporosis may be at an increased risk of serious inflammatory eye disease. Bisphosphonates such as Fosamax and Actonel, which are taken orally, are two of the most commonly prescribed drugs in that class. Published in […]
